Hexcel Medical: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Hexcel Medical” (first 1976, latest 1984), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 19 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITG | Bandage, Cast | 4 | 4 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 4 | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 1 | 1 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 1 | 1 |
Review panels
- Orthopedic (8)
- Physical Medicine (4)
- Microbiology (1)
Most recent Hexcel Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840416 | HEXCELITE | ITG | 1984-03-23 | 52 |
| K820890 | URETHANE ORTHOPAEDIC CASTING TAPE | ITG | 1982-06-23 | 85 |
| K812687 | BRIGHAM II TOTAL HIP SYSTEM | JDG | 1981-10-02 | 10 |
| K812669 | SEATTLE II TOTAL HIP SYSTEM | JDG | 1981-10-02 | 11 |
| K812068 | PROPOSED CONTROLS FOR DOSIMETRIC RELEASE | LIB | 1981-09-08 | 49 |
| K811164 | URETHANE ORTHOPAEDIC CASTING TAPE | ITG | 1981-05-27 | 29 |
| K810957 | MARCOVE INTRAMEDULLARY ROD | HSB | 1981-04-17 | 10 |
| K810956 | MARCOVE HUMERAL ROD | HSB | 1981-04-17 | 10 |
| K810230 | CONDYLAR KNEE W/METAL ENCAPSULATED TIB | HRY | 1981-03-06 | 38 |
| K800051 | HEXCEL FEMORAL COMPONENT HIP PROSTHESIS | JDG | 1980-01-28 | 19 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hexcel Medical.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hexcel Medical?
FDA lists 13 510(k) clearances under the applicant name “Hexcel Medical” (first 1976, latest 1984), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hexcel Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hexcel Medical is 19 days.
Which FDA product codes appear under Hexcel Medical?
The most frequent FDA product codes under this applicant name are ITG (Bandage, Cast, 4); JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal, 4); HSB (Rod, Fixation, Intramedullary And Accessories, 2).
Next steps
- See all 13 Hexcel Medical clearances with predicates and recalls
- Run predicate analysis for product code ITG, Hexcel Medical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.